Senior In-House CRA

Job Summary

Supporting the management and monitoring of clinical studies, the full-time Senior In-House CRA will assist with operational activities, ensure compliance with protocols and regulatory requirements, and provide mentorship to junior staff while working remotely.

Key responsibilities

• Independently collects, reviews, and tracks essential documents for clinical trials, ensuring compliance with regulatory requirements
• Communicates effectively with internal project staff and site personnel, coordinating responses to inquiries and managing trial progress updates
• Assists in audit preparation and provides training to site staff, while also tracking site recruitment efforts and issue resolution

Required qualifications

• Bachelor's Degree in a scientific discipline or directly applicable work experience
• 2-3 years of relevant clinical research experience (as a CTA, in-house CRA, study coordinator, etc.)
• Proficiency in MS Office Suite and strong organizational skills
• Knowledge of clinical research operations, including ICH guidelines and country-specific regulations
• Ability to work independently and collaboratively in a team-oriented environment